Foam Mattress Pads SYKCM-54384B1

GUDID 10850013699510

Convolute Mattress Topper 32" X 73" X 4"/5" Set

GENEVA HEALTHCARE, LLC

Freestanding patient positioner, single-use
Primary Device ID10850013699510
NIH Device Record Key0a1386b8-8d86-4f2c-a628-4a1f6f16aa21
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoam Mattress Pads
Version Model NumberSYKCM-54384B1
Catalog NumberSYKCM-54384B1
Company DUNS964459106
Company NameGENEVA HEALTHCARE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-262-767-9870
Emailinfo@genevahc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110850013699510 [Primary]

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-11
Device Publish Date2019-12-03

On-Brand Devices [Foam Mattress Pads]

20850013699500Convolute Mattress Topper 32" X 73" X 3"/3.5" Set
10850013699510Convolute Mattress Topper 32" X 73" X 4"/5" Set
10850013699503Convolute Mattress Topper 32" X 73" X 4"/4.5" Set
00810044960532Convolute Mattress Topper 32" X 73" X 3"/3.5" Set
00810044960525Convolute Mattress Topper 32" X 73" X 4"/5" Set
00810044960518Convolute Mattress Topper 32" X 73" X 4"/4.5" Set
00810044960921Convolute Mattress Topper 2" X 34" X 72" Density # 1.2
00810044960914Convolute Mattress Topper 2" X 34" X 80" Density # 1.2
00810044960907TWIN Convolute Mattress Topper 2" X 39" X 75" Density # 1.2
00810044960891TWIN LONG Convolute Mattress Topper 2" X 39" X 80" Density # 1.2
00810044960884Convolute Mattress Topper 2" X 50" X 72" Density # 1.2
00810044960877FULL Convolute Mattress Topper 2" X 54" X 75" Density # 1.2
00810044960860Convolute Mattress Topper 2" X 56" X 72" Density # 1.2
00810044960853QUEEN Convolute Mattress Topper 2" X 60" X 80" Density # 1.2
00810044960846Convolute Mattress Topper 2" X 72" X 72" Density # 1.2
00810044960839CALIFORNIA KING Convolute Mattress Topper 2" X 72" X 84"
00810044960822KING Convolute Mattress Topper 2" X 76" X 80" Density # 1.5
00810044960815Convolute Mattress Topper 3" X 34" X 72" Density # 1.5
00810044960808HOSPITAL FIT Convolute Mattress Topper 3" X 34" X 80" Density 1.35
00810044960792TWIN Convolute Mattress Topper 3" X 39" X 75" Density # 1.2
00810044960785TWIN LONG Convolute Mattress Topper 3" X 39" X 80" Density # 1.2
00810044960778Convolute Mattress Topper 3" X 50" X 72" Density # 1.2
00810044960761FULL Convolute Mattress Topper 3" X 54" X 75" Density # 1.2
00810044960754Convolute Mattress Topper 3" X 56" X 72" Density # 1.2
00810044960747QUEEN Convolute Mattress Topper 3" X 60" X 80" Density # 1.2
00810044960730Convolute Mattress Topper 3" X 72" X 72" Density # 1.2
00810044960723CALIFORNIA KING Convolute Mattress Topper 3" X 72" X 84"
00810044960716KING Convolute Mattress Topper 3" X 76" X 80" Density # 1.2
00810044960709Convolute Mattress Topper 4" X 34" X 72" Density # 1.2
00810044960693Convolute Mattress Pad Topper 4" X 34" X 80" Density # 1.2
00810044960686TWIN Convolute Mattress Topper 4" X 39" X 75" Density # 1.2
00810044960679TWIN LONG Convolute Mattress Topper 4" X 39" X 80" Density # 1.2
00810044960662Convolute Mattress Topper 4" X 50" X 72" Density # 1.2
00810044960655FULL Convolute Mattress Topper 4" X 54" X 75" Density # 1.2
00810044960648Convolute Mattress Topper 4" X 56" X 72" Density # 1.2
00810044960631QUEEN Convolute Mattress Topper 4" X 60" X 80" Density # 1.2
00810044960624Convolute Mattress Topper 4" X 72" X 72" Density # 1.2
00810044960617CALIFORNIA KING Convolute Mattress Topper 4" x 72" x 84"
00810044960600KING Convolute Mattress Topper 4" X 76" X 80" Density # 1.2
00810044961584Convolute Mattress Topper 2" X 32" X 73" Density # 1.2
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